ETO Sterilization Quiz - Vee Care Asia

ETO Sterilization Quiz

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1. Shallow vacuum processes are designed for sterilization of pressure-sensitive materials.

a) True

b) False

2. Microorganisms are microscopic entities, including bacteria, fungi, protozoa, and viruses.

a) True

b) False

3. Product family means a group possessing characteristics that allow them to be sterilized using defined process conditions

a) True

b) False

4. The overkill sterilization approach delivers a minimum of 12 Spore Log Reduction (SLR) to a biological indicator having a resistance equal to or greater than the product bioburden

a) True

b) False

5. Operation qualification OQ refers to the process of obtaining and forming documented evidence that equipment installed and operated in accordance with operating regulations consistently operates in accordance with pre-determined standards, resulting in a product meeting its specifications.

a) True

b) False

6. Performance qualification PQ is the process of obtaining and documenting evidence that the installed equipment operates within predetermined limits when used in accordance with operating procedures.

a) True

b) False

7. Sterilization outsourcing, the manufacturer must control the sterilization validation and packaging control of its sterilization outsourcer. The manufacturer shall bear the responsibility and risk and must carry out on-site evaluation and audit of the sterilization outsourcer.

a) True

b) False

8. Sterility is a state in which there are no living microorganisms.

a) True

b) False

9. The product family should be reviewed every 12 months.

a) True

b) False

10. The biological load of the most difficult part of the product can be effectively killed if it does not exceed the number of spores on the biological indicator (BI) used for sterilization and the resistance does not exceed the D value of BI.

a) True

b) False

1. Which of the following is the correct sequence of a deep vacuum cycle?

a) Pretreatment > Vacuum Suction > Humidification > ETO Injection > Product exposure to ETO > Vacuum + Nitrogen/air

b) Pretreatment > Vacuuming + Nitrogen/Air > Humidification > ETO Injection > Product exposure to ETO > Vacuum pumping

c) Pretreatment > Vacuum Pumping > ETO Injection > Humidification > Product exposure to ETO > Vacuum + Nitrogen/Air

d) Pretreatment > Vacuum Pumping > ETO Injection > Product exposure to ETO > Humidification > Vacuum pumping + Nitrogen/air

e) None of the above

2. Which of the following should be considered when dividing product families?

a) Product Design

b) Intended use

c) Production environment

d) Raw materials

e) All the above

3. Which of the following is NOT a critical success factor of an ETO sterilization cycle?

a) Bioburden

b) Package structure

c) Loading method

d) Cycle parameters

e) Thickness of sterilized item

4. What is the minimum number of temperature and humidity sensor for an ETO sterilizer chamber respectively?

a) 2, 1

b) 3, 2

c) 4, 3

d) 5, 4

5. How many temperature and humidity sensors are required for a 4m³ sterilization chamber during Operation Qualification (OQ)?

a) 2, 1

b) 3, 2

c) 4, 2

d) 4, 3

6. How many BIs are required for a product load volume of 3m³ during MPQ?

a) 5

b) 6

c) 7

d) 8

e) 9

7. What factors are used to determine the required number of BI/PCDs?

a) Microbiological Qualification Method Chosen

b) Product Volume

c) Chamber Type (Development/Production)

d) All of the above

e) None of the above

8. How many BIs are required for a product load volume of 18m³ during routine control?

a) 3

b) 5

c) 19

d) 27

e) 54

9. Which of the following is the purpose of conducting Bacteriostasis/Fungistasis (B/F) Test?

a) To validate the recovery of the biological indicator (BI) and establish the relationship between BI and the natural product bioburden.

b) To support the use of B. subtilis biological indicators as a release mechanism for the product following routine EO processing.

c) To confirm the microorganisms, present on the product sample will be detected in the course of the sterility test

d) None of the above

e) All of the above

10. Which of the following is the purpose of conducting fractional cycle test?

a) To validate the recovery of the biological indicator (BI) and establish the relationship between BI and the natural product bioburden.

b) To demonstrate the repeatability of a 6-spore log reduction of the BI utilizing minimum parameters, including one half of the intended routine exposure time

c) To determine ETO residues

d) To evaluate product/packaging functionality after sterilization

e) All of the above

11. Which of the following are factors to consider during the gas injection and gas retention phases?

a) Gas injection rate

b) Concentration of gas

c) Duration of exposure

d) Temperature of Gas

e) All the above

12. Which of the following is not the aim of post sterilization testing?

a) Device Functionality

b) Package integrity and strength

c) Residue dissipation rates

d) Correct Placement of biological indicator

e) Impact of re-sterilization

13. What is the minimum number of half cycle tests required for the overkill approach?

a) 1

b) 2

c) 3

d) 4

e) 5

14. Which of the following will BI survive?

a) Fractional Cycle

b) Half cycle

c) Full cycle

d) All of the above

e) None of the above

15. Which of the following sterilization sequences is correct?

a) Place BI > Chamber Loading > Environment Preconditioning > ETO Sterilization > Heated Aeration

b) Chamber Loading > Place BI > Environment Preconditioning > ETO Sterilization > Heated Aeration

c) Environment Preconditioning >Place BI > Chamber Loading > ETO Sterilization > Heated Aeration

d) Place BI > Environment Preconditioning > Chamber Loading > ETO Sterilization > Heated Aeration

e) Place BI > Chamber Loading > Environment Preconditioning > Heated Aeration > ETO Sterilization

16. Which of the following is not Gas Injection/Dwelling parameters?

a) Gas Injection Rate

b) Loading Pattern

c) Gas concentration

d) Exposure Time

e) Vacuum Rate

17. Which of the following is true?

a) EPCD Resistance > IPCD Resistance > Product Bioburden Resistance

b) Product Bioburden Resistance > EPCD Resistance > IPCD Resistance

c) IPCD Resistance > EPCD Resistance > Product Bioburden Resistance

d) EPCD Resistance > Product Bioburden Resistance > IPCD Resistance

e) EPCD Resistance > IPCD Resistance = Product Bioburden Resistance

18. What is the minimum time period of revalidation for a BI release process?

a) 3 months

b) 6 months

c) 1 year

d) 2 years

e) 3 years

19. What is the proper location for the biological indicator (BI) in the sterilized package?

a) The centre of the package

b) The site which is the most difficult to be sterilized

c) Package Edges

d) Uppermost location

e) Innermost location

20. What is the maximum allowed amount of EO residue for short-term exposure (1 day) devices, as per ISO 10993-7:2008?

a) 4mg

b) 10mg

c) 20mg

d) 60mg

e) 80mg

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